Problems with Minimal-Risk Research Oversight: A Threat to Academic Freedom?

Article excerpt

Although criticism of a powerful bureaucratic body is expected, your local institutional review board (IRB) might deserve a touch of sympathy, having been subjected to withering critique in recent years for a long list of sins. The observed faults of IRBs have been well summarized (1) and include inconsistency, delay, grammatical pedantry, excessive conservatism regarding legal risk, ignorance of fields reviewed, and threats to academic freedom. (2) Minimal-risk research is a particular area of controversy because the bureaucratic burden of human subjects research oversight seems severely disproportional to the potential risks of harm to research participants, as well as to the effort required to conduct the research itself.

Many of these complaints are legitimate, and IRB review of a researcher's proposed study can engender anger, frustration, and stress. Unfortunately, such responses can impede an accurate assessment of both the cause of the problem and its potential solution. A particularly unfortunate recent development is the labeling of some legitimate complaints as issues of academic freedom when they are not.

I will not settle here the fundamental issue of whether a convincing argument exists that IRB review poses a threat to academic freedom. Instead, I evaluate the arguments in a report issued recently by a committee of the American Association of University Professors. The report, "Research on Human Subjects: Academic Freedom and the Institutional Review Board," (3) was issued by Committee A on Academic Freedom and Tenure, which is the largest and oldest of the AAUP standing committees. In the report, Committee A argues that the federal regulations governing research with humans--known as the Common Rule--grant unchecked power to IRBs in a way that poses a threat to academic freedom. It is vital to phrase complaints regarding IRBs accurately, both to avoid diluting the importance of academic freedom and to have a reasonable chance of solving the problems that do exist. I argue here that Committee A does not make a strong case that IRB oversight of human subjects research poses a threat to academic freedom, and I offer a better explanation and resolution of the problem that Committee A identified.

Academic Freedom

Assessing the alleged threat that IRBs pose to academic freedom requires a working definition of the concept of academic freedom. However, no universal definition exists. Conrad Russell points out that the notion of academic freedom began as a way of asserting the independence of the early church from the government and had mainly to do with the protection of a sphere of "independent professional judgment, within which [the government] is incompetent to meddle"--in this case, spiritual values. (4) The notion was later expanded:

   So great a power of ideas, facing so great a power
   of the sword, could only survive if it established a very
   firm taboo on State interference in its own affairs in
   any shape or form. The Church, then, believed it could
   only preserve its liberty by preserving its liberties. (5)

This conception of academic freedom suggests that the way to protect professional autonomy is instrumentally, through liberties such as those recognized in the United States' Bill of Rights and its ancestors. No wonder, then, that academic freedom is similar to-and often conflated with-freedom of speech; but over time, the concept has shifted in meaning from a focus on the rights of institutions to the rights of individuals within institutions. Yet another interpretation of academic freedom is a consequentialist claim that granting it tends to bring about better results. (6) Which of these interpretations one subscribes to makes a dramatic difference in how one views federal involvement in research as impacting academic freedom.

Committee A does not offer an explicit definition of academic freedom, but it is reasonable to rely in the present essay on the AAUP's "1940 Statement of Principles on Academic Freedom and Tenure":

   Institutions of higher education are conducted for
   the common good and not to further the interest of
   either the individual teacher or the institution as a
   whole. …